If you have kidney problems or excess body water (ascites, pleural effusion), you must be closely monitored and your dose may be adjusted or stopped by your doctor.

Methotrexate (usually at high dosages) has rarely caused severe (sometimes fatal) blood/bone marrow problems (decreasing your body's ability to fight infections) and stomach/intestinal disease (such as bleeding) when used at the same time as non-steroidal anti-inflammatory drugs (NSAIDs such as indomethacin, ketoprofen). Therefore, NSAIDs should not be used with high-dose methotrexate. Caution is advised if you also take aspirin. NSAIDs/aspirin may be used with low-dose methotrexate such as for the treatment of rheumatoid arthritis if directed by your doctor. If your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually at dosages of 81-325 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details on the safe use of these drugs (such as close monitoring by your doctor, keeping the same doses of NSAIDs).

In rare instances, this drug may also cause liver problems when it is used for long periods of time. If you are using methotrexate long term, a liver biopsy is usually recommended.

Uses

Methotrexate is used to treat certain types of cancer or to control severe psoriasis or rheumatoid arthritis that has not responded to other treatments. It may also be used to control juvenile rheumatoid arthritis. Methotrexate belongs to a class of drugs known as antimetabolites. It works by slowing or stopping the growth of cancer cells and suppressing the immune system.

Early treatment of rheumatoid arthritis with more aggressive therapy such as methotrexate helps to reduce further joint damage and to preserve joint function.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

How to use Methotrexate (Anti-Rheumatic)

Read the Patient Information Leaflet if available from your pharmacist before you start taking methotrexate and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Methotrexate is a strong medication. The dosage and how often you take this medication are based on your medical condition and response to treatment. There are many different dosing schedules for this medication (especially for cancer treatment). Therefore, it is very important that you follow your doctor's instructions carefully. Take this medication by mouth as directed by your doctor.

For the treatment of psoriasis or rheumatoid arthritis, take this medication by mouth as directed by your doctor, usually once a week. It may take up to several months before you get the full benefit of this drug.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

Drink plenty of fluids while taking this medication unless your doctor tells you otherwise. Doing so helps your kidneys to remove the drug from your body and avoid some of the side effects.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Get medical help right away if you have any very serious side effects, including: weakness on one side of the body, neck stiffness, severe headache, vision changes, irregular heartbeat, mental/mood changes, seizures.

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as fever, chills, persistent sore throat, cough).

This medication can affect sperm production, an effect that may lower male fertility. Consult your doctor for more details.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

See also Warning section.

Before taking methotrexate, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Methotrexate can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Methotrexate must not be used during pregnancy. It may harm an unborn baby. It is important to prevent pregnancy during and after treatment with methotrexate. Therefore, males and females must use reliable forms of birth control (such as condoms, birth control pills) during treatment. Males should continue to use birth control for at least 3 months after the end of treatment. Females should continue to use birth control for at least 1 menstrual cycle after the end of treatment. If you become pregnant or think you may be pregnant, tell your doctor immediately.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

Methotrexate passes into breast milk and may harm a nursing infant. Therefore, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Interactions

See also Warning section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: acitretin, asparaginase, chloramphenicol, leflunomide, other drugs that can cause kidney problems (such as cisplatin), other drugs that can cause liver problems (such as azathioprine, sulfasalazine, retinoids such as isotretinoin), penicillins, phenytoin, probenecid, procarbazine, pyrimethamine, sulfa medications, tetracyclines.

Certain drugs that reduce stomach acid (proton pump inhibitors-PPIs such as esomeprazole, omeprazole, pantoprazole) may increase the amount of methotrexate in your blood. This effect may increase the risk of side effects, especially with high-dose methotrexate treatment. Ask your doctor or pharmacist for details and ways to lessen the risk of side effects.

Overdose

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include severe nausea and vomiting, and bloody stools.

Notes

Do not share this medication with others.

Laboratory and/or medical tests (such as complete blood cell counts, liver and kidney function tests, pregnancy test, chest X-ray) should be performed before you start treatment, periodically to monitor your progress, or to check for side effects. Consult your doctor for more details.

Missed Dose

It is important to take each dose at the scheduled time. If you miss a dose, contact your doctor or pharmacist immediately to establish a new dosing schedule. Do not double the dose to catch up.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

Information last revised January 2014. Copyright(c) 2014 First Databank, Inc.

Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, expect as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

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